BruxismNCT06457646
mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism
An observational study of Bruxism, run by University of Monastir.
Trial summary
The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are: Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism? Is there a… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- What is being tested?
- Genetic polymorphism
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2024to 17 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 170 participants will be included in this study.
Who may be able to join
- be above 18 years of age and have a confirmed diagnosis of bruxism
Who cannot join
- Systemic diseases,
- orofacial dysfunction,
- acute symptoms such as neurodegenerative diseases (specifically Parkinsons disease),
- Taking medication such as anxiolytics
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are:
- Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism?
- Is there a significant association between the rs6280 polymorphism of the DRD3 gene and bruxism?
Read more
Participants will:
Provide DNA samples for genotyping of the DRD3 (rs6280) and HTR2A (rs6313) polymorphisms.
Provide RNA samples to assess changes in the expression of HTR2A and DRD3. Researchers will compare the genetic data and RNA expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.
- Conditions
- Bruxism
- Being tested
- Genetic polymorphism
- Keywords
- Gene Expression, Bruxism, Sleep bruxism, Polymorphism, Genetic
- Medical subject headings
- Bruxism, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic polymorphismGenetic
The biological significance of HTR2A and DRD3 in bruxism remains unclear as molecular analyses, including genetic association studies, have not explored the mRNA expression of genes implicated in bruxism. This study aims to evaluate the influence of genetic polymorphisms affecting DRD3 (rs6280) and HTR2A (rs6313) on bruxism to identify potentially associated genotypes. Additionally, it aims to investigate the expression of HTR2A and DRD3 to elucidate their biological significance in bruxism.
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR-RFLP Analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start2 Jun 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion17 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosra Gassara, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457646
- Sponsor's protocol ID
- 011/2021
- Other IDs
- 0000-0002-5945-7764
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wieckiewicz M, Bogunia-Kubik K, Mazur G, Danel D, Smardz J, Wojakowska A, Poreba R, Dratwa M, Chaszczewska-Markowska M, Winocur E, Emodi-Perlman A, Martynowicz H. Genetic basis of sleep bruxism and sleep apnea-response to a medical puzzle. Sci Rep. 2020 May 4;10(1):7497. doi: 10.1038/s41598-020-64615-y.
PubMed 32367059Gassara Y, Foddha H, Chouchene S, Nasri S, Kallala R, Haj Khelil A, Hassin M, Ben Abdennebi H, Harzallah B. Analysis of genetic polymorphisms and mRNA expression of DRD3 and HTR2A in bruxism. BMC Oral Health. 2026 Jun 3. doi: 10.1186/s12903-026-08633-8. Online ahead of print.
PubMed 42237294
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism
- ClinicalTrials.gov ID
- NCT06457646
- Acronym / sponsor ID
- 011/2021
- Conditions
- Bruxism
- Keywords
- Gene Expression, Bruxism, Sleep bruxism, Polymorphism, Genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 2 Jun 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 17 Dec 2024 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are:
- Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism?
- Is there a significant association between the rs6280 polymorphism of the DRD3 gene and bruxism?
Participants will:
Provide DNA samples for genotyping of the DRD3 (rs6280) and HTR2A (rs6313) polymorphisms.
Provide RNA samples to assess changes in the expression of HTR2A and DRD3. Researchers will compare the genetic data and RNA expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 170 participants will be included in this study.
Key inclusion criteria (1 listed)
- be above 18 years of age and have a confirmed diagnosis of bruxism
Key exclusion criteria (4 listed)
- Systemic diseases,
- orofacial dysfunction,
- acute symptoms such as neurodegenerative diseases (specifically Parkinsons disease),
- Taking medication such as anxiolytics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic polymorphismThe biological significance of HTR2A and DRD3 in bruxism remains unclear as molecular analyses, including genetic association studies, have not explored the mRNA expression of genes implicated in bruxism. This study aims to evaluate the influence of genetic polymorphisms affecting DRD3 (rs6280) and HTR2A (rs6313) on bruxism to identify potentially associated genotypes. Additionally, it aims to investigate the expression of HTR2A and DRD3 to elucidate their biological significance in bruxism. | Genetic | – |
Primary outcome
PCR-RFLP Analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Results publication: PubMed 32367059Wieckiewicz M, Bogunia-Kubik K, Mazur G, Danel D, Smardz J, Wojakowska A, Poreba R, Dratwa M, Chaszczewska-Markowska M, Winocur E, Emodi-Perlman A, Martynowicz H. Genetic basis of sleep bruxism and sleep apnea-response to a medical puzzle. Sci Rep. 2020 May 4;10(1):7497. doi: 10.1038/s41598-020-64615-y.
- Derived from this study: PubMed 42237294Gassara Y, Foddha H, Chouchene S, Nasri S, Kallala R, Haj Khelil A, Hassin M, Ben Abdennebi H, Harzallah B. Analysis of genetic polymorphisms and mRNA expression of DRD3 and HTR2A in bruxism. BMC Oral Health. 2026 Jun 3. doi: 10.1186/s12903-026-08633-8. Online ahead of print.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, run by University of Monastir.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yosra Gassara (216-587-5455 ext. +216 55374741, chouchengassarayosra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR-RFLP Analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06457646, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.